I know it can be said about many areas of the law; however, the statue, regulations, and administrative caselaw governing controlled substances is truly a different animal. I frequently get calls from attorneys seeking advice on matters involving Drug Enforcement Administration investigations. Many have little to no experience with such matters. My first (and perhaps
Ignore Red Flags at Your Own Peril
Today, the Drug Enforcement Administration announced the revocation of Coconut Grove Pharmacy’s DEA registration.
DEA issued an Order to Show Cause and Immediate Suspension of Registration back in September 2022, premised on Coconut Grove’s alleged failure to identify, resolve, and document the resolution of potential red flags associated with prescriptions for controlled substances. If
Active Prosecution Continues for Controlled Substance Violations
The COVID pandemic notwithstanding, the Drug Enforcement Administration (DEA), Department of Justice and other federal and state agencies continue to actively pursue and prosecute pharmacies, pharmacists, doctors and others in the industry for violations of the Controlled Substance Act, False Claims Act and other controlled substance-related crimes.
I’ve compiled news reports on such cases from the last two months, confirming that prosecuting health care fraud and illegal distribution of controlled substances continues to be top of mind for law enforcement.
DEA’s New/Old View on Due Diligence Requirements
On September 30, 2020, DEA published a Final Rule (FR) adopting the Interim Final Rule (IFR) implementing the Ryan Haight Act. The FR made a few technical changes to the regulations and did not substantively change the IFR. What garnered my attention was DEA’s response to comments submitted after publication of the IFR.
Lawsuits Filed Against Retail Chain Pharmacies: The Corresponding Responsibility Catch-22
With the filing of two class action lawsuits, one against Walgreens and Costco, and one against CVS, in two federal district courts on August 6, pharmacies find themselves in a perplexing situation (yet again). For these suits were filed not by those who suffered from the over-dispensing of opioids, but by chronic pain patients who were denied opioid medication by pharmacies.
The Curious Case of Colorado: DEA Sues the BOP
DEA is investigating two pharmacies in Colorado. It doesn’t want those pharmacies to know it is investigating them. But it needs information relating to these pharmacies and the prescriptions they are dispensing to assist with its investigation. So DEA is doing what it does on a regular basis in many states. It is issuing subpoenas for the Colorado Prescription Drug Monitoring Program (“PDMP”) data relevant to these registrants. And Colorado is objecting.
Judge Dissolves ISO Against West Virginia Pharmacy: Suspicion Of Diversion Not Enough to Support Suspension
In a decision issued on October 30, Judge Joseph Goodwin of the Southern District of West Virginia dissolved an Order of Immediate Suspension of Registration (“ISO”) issued by DEA against Oak Hill Hometown Pharmacy, a West Virginia pharmacy. Without getting too far into the factual weeds of this case, I do think there are two or three critical takeaways related to both the adjudication of this matter and to DEA’s view of Subutex vs. Suboxone.
Key Takeaways from the Rochester Drug Co-Op Deferred Prosecution Agreement
As you undoubtedly should know by now, on April 22, 2019, the United States Attorney for the Southern District of New York entered into a Deferred Prosecution Agreement (the “Agreement”) with the Rochester Drug Co-operative, Inc. (“RDC”).
Specifically, the government announced that
“RDC agreed to accept responsibility for its conduct by making admissions and stipulating to the accuracy of an extensive Statement of Facts, pay a $20 million penalty, reform and enhance its Controlled Substances Act compliance program, and submit to supervision by an independent monitor.”
Federal Judge Overturns DEA’s Immediate Suspension Order…for now.
A United States District Court Judge issued a temporary restraining order prohibiting the Drug Enforcement Administration (DEA) from enforcing the Immediate Suspension Order issued against Morris & Dickson.
Acknowledging, that the entire administrative record was not before the court, Judge Foote nonetheless held that “Plaintiff has demonstrated a substantial likelihood that it will be able
Alleged Failure to Report Suspicious Orders Leads to Suspension
On May 2, 2018, the DEA issued an Order to Show Cause and Immediate Suspension of Registration (the “Order”) against Morris & Dickson Co., LLC (“M&D”), a drug distributor based in Louisiana with pharmacy customers in 7 states. The DEA has two main allegations against M&D:
- M&D failed to maintain effective controls against division of controlled substances into other than legitimate channels, in violation of 21 USC 823(b)(1) and 21 CFR 1301.71.
- M&D failed to identify and report suspicious orders to DEA, in violation of 21 CFR 1301.74(b).